Submission communications & appeal by country

The applicant may file a written appeal with the Ministry of Health against refusal of registration, amendment or cancellation in the National Register of Medical Devices; ministerial licensing decisions are appealable under Article 30 of Law No. 10081/2009 on licences, authorizations and permits; appeals against measures under the law follow the inspection legislation.

After an online application, responsible officers verify the documentation and the applicant is notified by e mail and in the 'Dokumentet e mia' section of their e Albania account about additional documents to be completed, issuance of the registration certificate, or the official justification for non issuance of the requested document.

A homologation application is refused after commission opinion on defined grounds (altered characteristics/performance, non conformity with the dossier, unfavourable safety report, inadequate manufacturing/control processes, insufficient documentation); any refusal notified by the ANPP Director General must be motivated.

Against a rejection of an export only homologation application, the establishment may file a recourse (recours) with ANPP within 30 days of notification of the rejection decision; for modifications, a corrected application addressing the rejection motives may be filed within 30 days of receipt, decided within 30 days.

ANPP Note N°39 2026 of 22 April 2026 governs the lifting of reservations raised on device homologation dossiers; Note N°47 2025 of 4 December 2025 governs the payment proof documents due for registration and device homologation requests.

A party may file a recurso de reconsideración (reconsideration appeal) against an ANMAT act within 20 days of notification, under the national administrative procedure regulation applicable to ANMAT decisions.

The recurso jerárquico (hierarchical appeal) must be filed before the authority that issued the challenged act within 30 days; acts of autarchic entities such as ANMAT may also be challenged by recurso de alzada before the Ministerio de Salud.

A person whose interests are affected by a reviewable initial decision may request the Minister for Health to reconsider it under s 60 of the Act (or reg 48 TG Regs 1990 / reg 10.7 MD Regs 2002); requests incur no fee and must generally be made within 90 calendar days of notice; if no decision issues within 60 days the initial decision is taken to be confirmed. Preliminary assessment refusals and s 41FH audit selection or s 41JA information request decisions are not reviewable.

A person dissatisfied with a Ministerial reconsideration decision may apply to the Administrative Review Tribunal (ART) for merits review; the application must be made in writing within 28 days after the day notice of the reconsideration decision is given, subject to the Administrative Review Tribunal Act 2024.

External merits review is now conducted by the Administrative Review Tribunal (ART), which replaced the Administrative Appeals Tribunal (AAT); all cases before the AAT immediately prior to 14 October 2024 were automatically transferred to the ART.

Where registration is suspended and production/marketing halted, the person or establishment may, within 30 working days, apply to the Licensing Authority for reconsideration of the order or file an appeal with the Government; parties must be given a hearing, and the decision of the Licensing Authority or the Government is final.

The Ministry of Health's commission on medical products handles applicants' disagreements with RUP CEIZ conformity conclusions and product qualification questions. Refusal of registration (reregistration) is only possible on grounds of the Law 'On the Basics of Administrative Procedures' № 433 З or where the same device is already registered by another applicant under the same trade name or required documents were not provided; decisions are taken by ministerial order and communicated within 5 working days.

A sponsor may lodge a gracious appeal (recours gracieux) with the minister or their delegate against refusal of a clinical investigation authorisation, within thirty days of publication of the refusal. The minister seeks the opinions of FAMHP and of a different ethics committee; under the 2026 amendment the minister must decide within three months, and authorisation requires both favourable opinions.

From acts practiced by ANVISA an appeal (recurso) lies to the Diretoria Colegiada, with suspensive effect, as the last administrative instance (Lei 9.782/1999 Art. 15 §2º); the appeal is filed within 30 days of publication/intimação (§3º) and decided within 90 days, prorrogable (§4º). Under RDC 266/2019 the second instance is the Gerência Geral de Recursos (GGREC) and the last is the Diretoria Colegiada Dicol.

Technical deficiency letters (exigência técnica) under RDC 204/2005 must be answered within 120 days, non extendable, counted from confirmation of receipt of the exigência; non compliance results in refusal (indeferimento) of the petition (Art. 11).

Since 17 February 2021, electronic deficiency letters that would previously be answered in the Sistema de Peticionamento Eletrônico must be answered through the Solicita system.

Refusals under ЗМИ (e.g. refusal of a clinical investigation application) are appealable under the Administrative Procedure Code (Административнопроцесуален кодекс).

Appeals against BDA market surveillance orders do not suspend execution of the contested order.

Where the Minister refuses to issue or amend a licence, the applicant must be notified in writing of the reasons for the refusal and be given an opportunity to be heard.

A manufacturer may seek reconsideration of a rejection or refusal decision by filing a request for reconsideration (RR) within 30 days; the Medical Devices Directorate then proceeds by an internal review or an external panel review pathway chosen by the Director General, with the DG reconsideration decision issued within 5 days of receiving recommendations.

Persons whose devices are rejected in the conformity verification by an authorized entity may claim in writing to ISP within 15 working days from communication of the non conformity (Art. 6). Separately, applicants for entity authorization denied or not answered within 30 working days may claim in writing to the Ministry of Health within 15 working days (Art. 14), resolved by founded resolution.

Once evaluation starts, if problems are detected in the submitted documents, the applicant receives an email notification with the details of the observations to be cured; the resolution is notified by email and is available in the 'Trámites Finalizados' section of the user's SAFIS account; queries run through the ISP online OIRS citizen attention platform (siac.ispch.gob.cl).

Applicants who disagree with an approval conclusion on NMPA licensing items may seek administrative reconsideration (行政复议) by NMPA or file administrative litigation (行政诉讼).

During registration evaluation INVIMA may request additional information only once; the applicant must supply it within 90 days, failing which the petition is deemed withdrawn (desistimiento) with no refund of the fee.

Against definitive INVIMA administrative acts, the general administrative remedies are recurso de reposición (filed before the authority that issued the decision) and recurso de apelación (before the immediate administrative or functional superior); both must be filed in writing at personal notification or within 10 days of it; the apelación is required before going to court and may be filed as subsidiary to reposición.

An interested party aggrieved by a final decision or sanction applied by CECMED may request Reconsideración of the measure before the Director General of CECMED, under the CECMED regulation 'Quejas, Reclamaciones y Reconsideración de Decisiones Reguladoras'; if the disagreement persists after CECMED's response, the party may file a Recurso de Apelación before the Minister of Public Health within the term set by that authority's rule.

If the conformity assessment process ends in denial of the Registro Sanitario, the manufacturer is notified with the evaluation report stating the grounds; the manufacturer may not file a new registration application for the device in question until 6 months have passed.

SÚKL issues a decision on preventive (safeguard) measures under MDR Art. 98 / IVDR Art. 93; an appeal against this decision has no suspensive effect.

Deficiencies are handled by returning the file (trámite) to the applicant for cure: documentary stage objections get one 5 day cure window (2026 regime) or correction rounds under the current 2016 regime; post technical evaluation objections get cure rounds (30 days national / 60 days foreign under the 2026 regime; 30 days with max two rectifications under the 2016 regime). Failure to cure or to pay within the window leads to automatic cancellation with status 'solicitud no aprobada'; a new application with new fee payment is then required and the paid inscription/modification fee is not reimbursed (Art. 18).

Applicants may appeal a Scientific Committee or Import Committee rejection by submitting new documents not previously presented or a scientific explanation of the rejection points.

Requirements are sent to the company by e mail/platform and must be fulfilled within 60 working days (registration workflow); suspended files are completed on the platform under the same request number, hard copy submission may be scheduled for variations, and rejected requests state the mismatch grounds (data vs payment receipt/required documents or wrong department).

Where a clinical investigation application is incomplete or out of scope, the Member State informs the sponsor and sets a maximum 10 day limit (extendable by 20 days) to comment or complete via the electronic system; if the sponsor does not respond in time the application is deemed to have lapsed; if the sponsor disputes the Member State's view the application is treated as rejected, and the Member State concerned shall provide an appeal procedure (Art. 70(3) MDR). Refusals of authorisation after assessment likewise carry a Member State appeal procedure (Art. 71(4) second subpara MDR). There is no EU level appeal forum against notified body decisions; NBs must operate complaints and appeals procedures under their QMS (Annex VII MDR) and Member States lay down penalties (Art. 113 MDR).

A decision made by Fimea or a notified body under MDR, IVDR or the national act may be challenged by seeking rectification (oikaisu) as provided in the Administrative Procedure Act; appeal to an administrative court is governed by the Act on Judicial Procedure in Administrative Matters (808/2019).

ANSM is the responsible authority for notified bodies under Article 35 of Regulations (EU) 2017/745 and 2017/746, handling their evaluation, designation, re assessment and joint assessments with EU experts; recourse concerning notified body oversight in France therefore lies with ANSM, which is confirmed as competent authority including for classification disputes (MDR Art. 51(2), Art. R5211 5 CSP).

Where the Authority refuses registration or approves it subject to conditions, the Chief Executive Officer shall inform the applicant in writing of the decision and the reasons within thirty days of the refusal or approval.

An applicant not satisfied with a registration decision may make representations to the Authority within sixty days after notification; if the Authority remains unsatisfied it shall reject the application.

Responses to all queries in a deferral letter must be provided in one submission; if queries are reissued a third time and responses remain unsatisfactory, the application is rejected.

An applicant may withdraw a registration application at any time, but withdrawal does not entitle the applicant to a refund of the application fees.

In the event of rejection of a clinical trial application, the applicant may appeal to the Minister of Health within sixty days in writing, giving grounds for review; absent a representation within that period the Authority's decision stands.

The LRP may appeal against rejection, conditions imposed on a conditional approval, or removal from the List of Medical Devices within fourteen (14) working days of notification; late appeals are not considered.

The LRP is notified of the appeal outcome within four (4) weeks of submission of the appeal and all required supporting information; the Appeal Committee decision is final; lodging an appeal does not suspend the MDD decision unless MDD decides otherwise.

NNGYK provides a remedy procedure (jogorvoslati eljárás) against rejecting decisions; stated for rejections of clinical investigation applications, e.g. for omitted fee payment.

NNGYK treats the EUDAMED Actor data upload as an application (kérelem) under the general administrative procedure code (2016. évi CL. törvény, Ákr.); deficiencies are communicated by decision (végzés) via cégkapu and are remedied by editing the original APP request in EUDAMED.

An applicant whose import licence application is rejected may appeal to the Central Government within forty five days; the Government decides within ninety days of the appeal. Documents found misleading, fake or fabricated lead to summary rejection after opportunity of hearing (rule 92), with possible debarment (rule 93, appeal within thirty days).

Against a CLA order under rule 43A (suspension, cancellation, stop import or destruction of an import licence), the aggrieved person may appeal to the Central Government within thirty days of service of the order.

Applicants receive notification of the izin edar issuance or the digitally signed rejection letter by e mail and SMS to the registered company contact, and download the license or rejection letter electronically via regalkes.kemkes.go.id. Applications failing safety/quality/benefit requirements receive a rejection letter; the paid PNBP fee is not refunded for rejected applications.

All steps of application, tracking and issuance of the manufacturing license are electronic; the official service charter shows the internet channel (through imed.ir) as the sole enabled service channel.

Questions on tracking label XML files are submitted as tickets to the FDA support system at support.ttac.ir (section 'مشکلات فایل‌های شناسه رهگیری و ردیابی (XML)') and are answered within 48 hours.

A sponsor may appeal HPRA decisions within 28 days of receipt: refusal of clinical investigation authorisation (MDR Art. 70(3)), decisions under Art. 71(4), and refusal of substantial modification authorisation (Art. 75(3)(a)); HPRA publishes guidelines on appeal procedures.

IVD performance study decisions may be appealed to HPRA not later than 30 days after notice of the decision: Article 66(3) authorisation refusals, decisions under Article 67(4), and refusal of authorisation for a substantial modification under Article 71(3)(a).

HPRA appeals for clinical investigation objections (and clinical trial non acceptances) are submitted to the relevant statutory Advisory Committee within 28 days of notification and decided by the Authority (the nine HPRA members); classification decisions are appealed to the HPRA Leadership Team. HPRA states only classification decisions and objections to clinical trials and clinical investigations are appealable, and an appeal fee applies per the Guide to Fees.

An application may be transferred from the regular track to the fast track via a cover letter requesting the transfer, a signed affidavit and an updated marketing data document. Document requirements are identical across tracks; the difference is the required declaration document (fast track requires a lawyer affirmed affidavit). If no intake confirmation arrives within 7 days, the application must be resent.

Before adoption of any denial or restriction measure (including clinical investigation measures, bans or limitations on placing on the market, making available, withdrawal or recall), the addressee, where identified or identifiable, must be invited to present counter arguments (controdeduzioni), unless urgency makes this impossible; every such measure must be motivated (Art. 20(1)).

In case of serious risk to public health, the Ministry adopts measures urgently without prior counter arguments; the measures are notified to the addressee together with the grounds and a deadline of no more than 30 days to present elements unequivocally proving the device's conformity; if the 30 days lapse unfulfilled or the elements are insufficient, the Ministry notifies the finality of the measure by reasoned act (Art. 20(4)).

Denial and restriction measures (including urgent ones) are notified to the interested party with an indication of the deadline within which an appeal (ricorso) may be brought.

Where the reduced payment of an administrative sanction has not been made, the authority competent to receive the report under Art. 17 of Law 689/1981 is the Prefetto (Prefect); sanctions are ascertained by the surveillance organs and Ministry of Health offices per their competences (Art. 27(49)), and Law 689/1981 Chapter I applies for matters not covered (Art. 27(52)).

Applicants can file a formal appeal (審査請求) with MHLW against PMDA dispositions (other than review results) or inaction in medical device reviews; MHLW is treated as PMDA's superior agency for the appeal.

The responsible pharmacist or authorized person may object to any decision issued under Testing Regulation 41/2024 before the Objections Committee (formed under Art. 13 of the Law) within 30 days of being notified of the decision, attaching grounds and supporting documents.

The Objections Committee (chaired by the Director General) reviews objections to decisions issued under the Law and must decide within one month of filing the objection; its decisions are final.

Before a negative decision the services provider holds a hearing under Art. 73 of the Administrative Procedural Processual Code, notifying the applicant at least 3 working days in advance; the applicant may submit an objection to the preliminary decision no later than 2 working days after receipt.

The applicant must answer the authority's query within 60 working days of receipt; the query period is excluded from the authority's procedural timelines.

Under the 2026 single window registration rules the review timeline is suspended while the applicant cures deficiencies noted in the documents; on additional questions the applicant answers within 25 working days (expertise rules for devices).

Under rule 5(5) of the 2022 Registration Rules the Board may only reject an application after providing the applicant an opportunity to be heard, and must inform the applicant of the reasons for rejection in writing; under rule 11(3) the Board must give notice and an opportunity to be heard before suspension or cancellation of a certificate.

Under section 42B of the Pharmacy and Poisons Act, appeals against specified decisions (under ss. 27(2), 28(3), 32(5), 50(2)) shall be in writing and lodged within thirty days after the date of the act appealed against; certain refusals/revocations under s.27(2) lie to the Cabinet Secretary, whose decision is final.

Appeals against decisions of the Amt für Gesundheit (or the Amt für Lebensmittelkontrolle und Veterinärwesen) may be lodged with the Government within 14 days of notification; appeals against Government decisions go to the Verwaltungsgerichtshof (Administrative Court of Appeal) within 14 days.

Medical device market subjects have the right to appeal decisions of the institution empowered by the Minister of Health (VASPVT) under the procedure established by the Law on Administrative Proceedings of the Republic of Lithuania (Administracinių bylų teisenos įstatymas).

VASPVT refuses registration where the submitted documents are incomplete (or improperly formalised, or the device non conforming) and the person fails to remedy the indicated deficiencies within 30 days from receipt of the deficiency notice.

ISAF conducts a formal review of registration applications within 20 working days of receipt; incomplete applications trigger a notification to correct within a specified period, and failure to correct or lack of standing results in non acceptance; the same correction mechanism applies at substantive review, and the review clock is suspended during correction.

Administrative acts issued under Law 12/2025 (including registration decisions) may be appealed directly to the Administrative Court.

Query responses during evaluation are submitted in MeDC@St with a written response to each input request query, referencing uploaded file names (Class A: Section 10 'Any related information'; Class B/C/D: CSDT Misc section); the Authority may refuse registration on grounds including non provision of mandatory information within 30 working days, inaccurate classification, non medical device status, or revoked establishment licence.

A person aggrieved by an Authority decision under sections 7, 9, 12, 14, 18, 22, 24, 30, 33, 35, 45 or 46 of Act 737 may appeal to the Minister: a copy of the notice of appeal must be sent to the Minister by registered post within thirty days of the decision, stating the appellant's particulars, the decision, the grounds and supporting documents, accompanied by the appeal fee (RM250 per Fifth Schedule); the Authority submits its reasons within 30 days, and the Minister may confirm, reverse or vary the decision, which is final and binding.

Deficiency requests (prevención) in COFEPRIS trámites, and the applicant's deadline to cure them, are governed by Article 17 A, second paragraph, of the Ley Federal de Procedimiento Administrativo (as listed in the official ficha foundations); several device clocks carry positive silence (deemed approval) rules Class I registration (RIS Art. 179), modifications (RIS Art. 188) and prórrogas (RIS Art. 190 Bis 6) and the ficha records the ficta framework (LFPA Art. 17, second paragraph, and the 2011 RFTS Acuerdo, Art. Décimo primero).

Decisions on clinical investigations with medical devices can be challenged through national routes: administrative appeal to the CCMO against a decision of an accredited MREC (medical research ethics committee), objection against a CCMO decision, and objection against negative validation of the investigation file.

Because WAND is a notification only system with no application decision, deficiency responses and appeal rights for market entry do not arise; Medsafe states notification does not mean or imply a device has been assessed for quality, safety, efficacy or performance. WAND access and submission problems are handled through devices@health.govt.nz.

Failure to respond promptly to NAFDAC queries or enquiries on an application (within ninety (90) days) will automatically lead to closure of the application.

Clients must comply with a NAFDAC Compliance Directive (CD) within 7 working days of issuance; failure to comply with any CD may result in cancellation of the application.

Delays caused by the client are not counted within the registration processing timelines.

Individual decisions (enkeltvedtak) of Direktoratet for medisinske produkter may be appealed under the Public Administration Act § 28 to the immediately superior administrative organ (for a directorate, the ministry); the CA's clinical investigation pages expressly state that sponsors may appeal rejections of applications.

Under rule 60, an aggrieved person or party may prefer an appeal before the Appellate Board of the Authority against a decision of the MDB within sixty days. A fee for appeal is provided in Schedule C of the rules (PKR 50,000 as consolidated till April 2022; PKR 64,800 under S.R.O. 1399(I)/2025 row 132).

Sanctions imposed under Ley 90 are appealable by recurso de reconsideración and recurso de apelación, both granted in devolutive effect; resolution of the appeal exhausts the governmental avenue (vía gubernativa).

For device procedures, Reconsideración is filed and answered before the Director(a) Ejecutivo(a) of the Dirección de Dispositivos Médicos y Productos Sanitarios (max 15 business days to file, 15 to resolve); Apelación goes to the Director(a) General of DIGEMID (15 business days to file, 30 to resolve). Reconsideración requires new evidence; Apelación covers differing interpretation of evidence or pure law questions.

Where DIGEMID raises observations to documentation or technical information in inscripción/reinscripción, failure to cure them within a maximum of 30 business days from notification is a ground for suspension or cancellation of the registration.

Applications with deficiencies are given a one time compliance period of a maximum of ninety (90) calendar days; non compliance means the application is disapproved; the applicant may re apply within sixty (60) calendar days after disapproval, with corresponding fee; unclaimed disapproved applications are destroyed after 90 calendar days.

FDA orders, rulings or decisions become final and executory fifteen (15) days after receipt by the adversely affected party unless an administrative appeal is perfected within that period; one motion for reconsideration may be filed and suspends the running of the period.

FDA orders, rulings or decisions are appealable to the Secretary of Health; an appeal is perfected upon filing the notice of appeal and posting the corresponding appeal bond; the appeal does not stay the decision unless the Secretary issues a stay order.

A refusal of a clinical investigation application (or an application under Art. 29 30) is issued as a decision; the factual and legal justification is drawn up within 30 days of the decision, and the time limit for filing an appeal runs from the delivery of that justification.

An appeal from an opinion (opinia) of a bioethics commission lies to the Appellate Bioethics Commission (Odwoławcza Komisja Bioetyczna) at the Minister of Health.

Decisions restricting, conditioning or prohibiting the placing on the market of devices must be reasoned and notified to addressees (to the registered e mail address, per the Administrative Procedure Code); such decisions may be appealed under the general terms.

Decisions on clinical investigation applications, notifications and substantial modifications may be challenged by administrative impugnation (hierarchical appeal to the member of Government responsible for health) and by judicial review under the general terms of law.

Authorisations, rejection decisions and suspensions for clinical investigations can be contested by the sponsor at ANMDMR within 30 days of receipt; a contestation commission (minimum 3 members not involved in the evaluation) meets within maximum 30 days, and the ANMDMR president's decision is communicated within maximum 7 days of the session; further appeal lies to the competent administrative courts.

If the clinical investigation dossier is incomplete or out of scope, ANMDMR sets a maximum 10 day term for the sponsor to transmit completions, extendable by maximum 20 days for complex information; failure to complete in time makes the request caduc (lapsed) without a separate decision; rejection decisions are communicated within maximum 5 days.

Where violations are identified during registration, the applicant is notified and must rectify them within a 30 day period; time to respond to that notification is excluded from the review clock; a dedicated official form 'Application for resumption of state registration of a medical device' exists.

On the Russian manufactured device route, the FGBU VNIIMT expertise query is sent once and must contain an exhaustive list of all questions; the applicant must respond within no more than 35 working days.

SFDA must notify the applicant of the reasons for refusal of an MDMA application, and the applicant may object to the refusal in accordance with the applicable legal procedures.

Appeals against SFDA penalty decisions (Art. 42.1 of the Law) are heard by a Board formed Committee of at least 3 members including at least one legal advisor; the Committee's decisions may be appealed before the Administrative Court. Violations under Art. 42.2 are referred to the Public Prosecution and the competent court. Persons affected by violations may claim compensation before the competent court.

An appeal may be filed to the Ministry of Health against ALIMS decisions on registration and its amendments/renewal/removal, clinical trial approvals, pharmacopoeia compliance assessment, recognition of foreign documents and marks of conformity, technical assessment, product status determination, and import/export approvals. The Ministry's decision is final in the administrative procedure and an administrative dispute may be initiated against it. Entrusted tasks follow the general administrative procedure law unless the Law provides otherwise.

Persons affected by HSA decisions refusal of registration (s 30), imposition of conditions (s 32), reclassification (s 36), suspension or cancellation (s 37) may appeal in writing to the Minister within the time specified in the notice; the Minister's decision is final, and decisions take effect pending appeal unless the Minister directs otherwise.

ŠÚKL serves its deficiency notices and other outgoing documents (výzvy) on Slovak legal entities exclusively electronically to their seat address via www.slovensko.sk; Slovak natural persons receive them electronically only if their box is activated (otherwise paper conversion via Central Official Delivery), and foreign applicants without an activated box receive a paper copy of the electronic document. Follow up documents must quote the case number and handling officer.

JAZMP decides administrative matters at first instance under the general administrative procedure act (ZUP); appeals against JAZMP decisions are decided by the Ministry of Health.

Minor offences under ZMedPri 1 (60 listed violations, e.g. failing to provide the Slovenian IFU translation, not reporting data changes, lacking compliance/vigilance persons): fines EUR 800 4,000 for legal persons, 500 3,000 for sole traders, 200 1,000 for responsible persons, 100 500 for individuals; serious offences (78 listed, mainly substantive MDR/IVDR breaches incl. not reporting serious incidents to JAZMP): EUR 8,000 120,000 for legal persons, 5,000 50,000 sole traders, 500 5,000 responsible persons, 400 4,000 individuals.

A person aggrieved by a decision of the Council may lodge a written appeal within 30 days of being notified of the decision, to the Chairperson of the Council for attention the Registrar; the Registrar must within 30 days meet the appellant to try to resolve the matter, failing which the appellant may within 30 days (on payment of the prescribed fee) request the Minister to convene an appeal committee, which must decide within 30 days of its first hearing.

An advertiser disagreeing with a deliberation result may request re deliberation (재심의) to the self deliberation body within 30 days of notice; a person disagreeing with the re deliberation result may file an objection (이의신청) with the MFDS Commissioner within 30 days of notice.

During preliminary review (예비심사검토) of an application, missing attachment items may be submitted within 5 days.

Resolutions of AEMPS in the licence procedures of RD 192/2023 end the administrative route (ponen fin a la vía administrativa), so no ordinary administrative appeal (recurso de alzada) lies against them; the addressee may still use the optional reposición remedy or challenge the decision before the administrative courts.

If an application fails in the evaluation/committee process, the local agent can appeal for the registration.

Deficient documents or data are communicated to the applicant by email through the evaluation report; the applicant must submit the required deficient data or documents with the relevant payment within two months from the date of the email to the accepting point, failing which the application is given 'awaiting data' status.

Decisions under the national act may be appealed to a general administrative court (allmän förvaltningsdomstol); leave to appeal is required for appeal to the administrative court of appeal (kammarrätten). In practice, refused fee reductions have been appealed to Förvaltningsrätten.

Insofar as the Therapeutic Products Act does not provide otherwise, administrative procedure and legal protection are governed by the Federal Act of 20 December 1968 on Administrative Procedure (VwVG, SR 172.021), the Administrative Court Act and the Federal Court Act Swissmedic decisions follow the ordinary Swiss administrative justice track.

In clinical investigation procedures, the ethics committee confirms receipt of the application within 10 days and notifies formal deficiencies, setting a 10 day period to cure them (with notice that the application will not be entered upon if not corrected in time); the decision is issued within 40 days of confirmation of formally correct documents.

Applicants whose registration, filing or clinical trial applications are not approved may file one reconsideration request (申復) within four months of delivery of the decision, on procedural or technical grounds.

Against administrative fine decisions, the party may submit a written objection and request review within 15 days of delivery of the decision notice (once only); if unresolved, administrative appeal (訴願) and administrative litigation are available.

A person aggrieved by a decision of the Authority may appeal to the Minister against that decision; the Authority may appear as respondent and be heard, and the Attorney General may intervene.

An applicant aggrieved by a TMDA registration decision may first make representations in writing to TMDA; if still unsatisfied with the decision, the applicant may appeal to the Minister responsible for Health.

Refusals (non issuance or non renewal of establishment registration, licence, detailed listing receipt or notification receipt) may be appealed in writing to the Minister within 30 days of receiving notice; the Minister's decision is final, and for non renewal appeals the Minister may allow the operator to continue business pending decision.

When a detailed notification application is refused, the authority must send written notice to the applicant with the reasons and appeal rights within 15 days of the refusal order.

For clinical investigations, the sponsor may object to Kurum decisions (including validation/scope determinations) through the objection procedure established by the Kurum.

Держлікслужба may leave a register notification without consideration where it is submitted by an unauthorized person, lacks required data, contains data inconsistent with the attached documents, documents violate electronic document formatting requirements, or required documents are missing; resubmission is possible after remedying deficiencies.

Written/electronic appeals to Держлікслужба must be reviewed within one month (15 days for simple matters, absolute cap 45 days); a complaint against actions or inaction of a state body may be filed under subordination with a higher body or official, without prejudice to court review.

A person affected by any decision issued under Decree Law 38/2024 may file a grievance before the Grievance Committee (formed by decision of the Chairman, Minister or head of the local health authority) within 15 days of becoming aware of the decision; the Committee must decide within 30 days by reasoned decision; silence is deemed rejection; the grievance decision is final.

MHRA has appointed the Chartered Institute of Arbitrators (CIArb) as its dispute resolution service for: clinical investigation notifications (UK MDR regs 16 and 29), refusals of clinical investigation and performance study applications in Northern Ireland, notified body or UK approved body designation decisions (reg 45), and applications for exceptional use of non complying devices (regs 12, 26 and 39); CIArb does not handle administrative complaints.

A person served with an enforcement notice under the Medicines and Medical Devices Act 2021 may apply to court to revoke or vary the notice within 28 days of the notice being served to a magistrates' court (England and Wales), the sheriff (Scotland), or a court of summary jurisdiction (Northern Ireland).

A PMA applicant who receives a not approvable letter or an order denying approval may request administrative review under section 515(d)(4) and (g) of the FD&C Act, as referenced in 21 CFR 814.40(a).

Before sanctions under Decreto 3/008 are applied (fines from a minimum of 30 Unidades Reajustables, suspension up to permanent cancellation of registration, annulment and criminal referral in case of fraud), the company is granted a period of 10 working days (vista) to respond.

Applicants answer MSP observations within the 90 day cure window (Art. 11); under the MSP manual, once first observations are issued the company has a maximum of 3 months to lift them or the application restarts as new, and three or more observation rounds lead MSP to consider rejecting the product; an FO 13222 017 form allows requesting prioritisation of product evaluation.

The applicant has the right to complain, in the established procedure, against refusal of registration and against actions (inaction) of officials of the Centre. Refusal of registration is allowed only on the exhaustively listed grounds (uncured 60 day deficiencies, unreliable/false information, previously used samples, substantiated negative conclusions of laboratory/clinical/inspection/expert evaluations); refusal on other grounds, including inexpediency, is not allowed.

Deficiency notices are sent through the information system with 30 working days to cure acceptance stage deficiencies (failure leads to a refusal decision, after which a new application is treated as newly filed) and 60 working days for specialized expertise deficiencies; the certificate (Annex 4 form) or a reasoned refusal is sent to the applicant within 2 working days of the decision.

Decree 98 designates the authority competent to resolve Class C/D registration dossiers in a dedicated article (Art. 30); since 22/11/2025 this authority is IMDA.